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CTRI Number  CTRI/2026/01/100335 [Registered on: 05/01/2026] Trial Registered Prospectively
Last Modified On: 04/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Comparative Evaluation of Anxiety Levels in children Patients using Distraction Technique with Birds and bird video 
Scientific Title of Study   Comparative evaluation of anxiety in children during class I restoration using distraction technique with live and virtual birds: a clinical study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Julita Joseph 
Designation  postgraduate  
Affiliation  The Oxford Dental College 
Address  Department of Pediatric and Preventive Dentistry,
4th floor, room no. 8
Bangalore
KARNATAKA
560068
India 
Phone  09990565773  
Fax    
Email  julitajoseph23@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bharath Vardhana 
Designation  postgraduate  
Affiliation  The Oxford Dental College 
Address  Department of Pediatric and Preventive Dentistry,
4th floor, room no. 8
Bangalore
KARNATAKA
560068
India 
Phone  9886588595  
Fax    
Email  bharath.dentist@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Julita Joseph 
Designation  postgraduate  
Affiliation  The Oxford Dental College 
Address  Department of Pediatric and Preventive Dentistry,
4th floor, room no. 8
Bangalore
KARNATAKA
560068
India 
Phone  09990565773  
Fax    
Email  julitajoseph23@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Dr Julita Joseph 
Address  The Department of Pediatric and Preventive dentistry The Oxford Dental college, Bangalore- 560068 
Type of Sponsor  Other [Private Dental College] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Julita Joseph  The oxford Dental College  Department of Pediatric and Preventive Dentistry, 4th floor, room no. 8 The Oxford Dental College, Bangalore The Oxford Dental college
Bangalore
KARNATAKA 
09990565773

julitajoseph23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr Julita Joseph  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  children coming for dental checkups 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Children aged 6-8 who which fulfill the criteria will be selected. Prior written consent for performing treatment will be obtained from the parents.
The demographic details, brief case history and clinical findings of each patient will be recorded.
Following clinical examination, the Animated Emoji Scale (AES) and Raghavendra, Madhuri, Sujata (RMS) Pictorial Scale (RMS-PS) will be explained to the patient.
The children will be randomly divided into two groups of 15 each:
Group 1:the treatment will be performed in the presence of the birds and anxiety level will be measured at baseline, during treatment and after treatment. Animated Emoji Scale (AES scale) and Raghavendra, Madhuri, Sujata (RMS) Pictorial Scale (RMS-PS) would be used at the start and completion of the treatment.
Group 2: the treatment will be performed in the presence of the audiovisual of birds and anxiety level will be measured at baseline, during treatment and after treatment. Animated Emoji Scale (AES scale) and Raghavendra, Madhuri, Sujata (RMS) Pictorial Scale (RMS-PS) would be used at the start and completion of the treatment.

 
 
ExclusionCriteria 
Details  1. Children who have phobia towards birds
2. Children who have respiratory problems.
3. Children who have allergy to dust
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the effect of presence of live birds as distraction to reduce anxiety in pediatric patients.
2. To compare the effect of presence of audiovisual of birds in reducing anxiety in pediatric patients.
 
assessment will be done
1. before treatment
2. during treatment
3. after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
nil   
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Distraction techniques in Pediatric Dentistry are crucial for managing anxiety and fear in young patients, ensuring a positive dental experience. Dentistry exposes patients to an environment and particular experiences that trigger a natural response of fear in many people. Dental anxiety can be defined as a state where an individual is evoked and prepared for something to happen, with a non-specific feeling of apprehension associated with abnormal conditions. Dental anxiety is majorly seen in children, Fear and anxiety in children might trigger behavioural management problems during dental appointments manifesting as inability or difficulty to cooperate and engage during dental treatment and delivery of oral care advice. There are various methods of distraction that dental professionals can employ, tailored to the child’s age, preferences, and level of anxiety. Visual distractions, like cartoons or movies played on a screen, are popular in pediatric settings, capturing the child’s attention and making them less aware of the treatment environment. Auditory distractions, such as listening to music or stories through headphones, can also help mask potentially distressing dental sounds, like the noise of dental drills. Additionally, interactive distractions like handheld video games, tablets, or virtual reality (VR) devices offer immersive experiences that keep the child engaged, often minimizing their anxiety considerably.

Using live birds as a distraction technique in dental treatment is an innovative and natural approach that can help ease patient anxiety, especially in children. Birds, with their vibrant colors, gentle chirping, and playful behaviour, offer a unique sensory distraction that can calm nerves and engage patients’ attention. The presence of birds—whether in a viewing area near the waiting room, an aviary in the office, or through video screens with soothing bird imagery and sounds—can provide a comforting and visually engaging experience that diverts attention away from the treatment.

 
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